NCT00040937|CompletedPhase 2ResultsDMC

S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma

A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)

SWOG Cancer Research Network ClinicalTrials.gov

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2 other identifiers

S0204U10CA032102

Study Type

interventional

Target

147

Locations

1 country

Sites

141

Timeline

RegisteredJan 2003

StartedJun 2002

CompletionOct 2015

Brief Summary

RATIONALE: Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving thalidomide before and after peripheral stem cell transplant may be effective in treating newly diagnosed multiple myeloma. PURPOSE: This phase II trial is studying how well giving thalidomide with chemotherapy and peripheral stem cell transplant work in treating patients with newly diagnosed multiple myeloma.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

147

participants targeted

Target at P75+ for phase_2 multiple-myeloma

Timeline

Completed

Started Jun 2002

Longer than P75 for phase_2 multiple-myeloma

Geographic Reach

1 country

141 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

13.3 years study duration

Study Start

First participant enrolled

June 1, 2002

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2002

Completed

7 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed

4.8 years until next milestone

Results Posted

Study results publicly available

July 17, 2013

Completed

2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed

Last Updated

December 8, 2016

Status Verified

October 1, 2016

Enrollment Period

6.3 years

First QC Date

July 8, 2002

Results QC Date

October 31, 2012

Last Update Submit

October 26, 2016

Conditions

Multiple Myeloma

Keywords

stage I multiple myelomastage II multiple myelomastage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

Overall Survival
4-7 years

Secondary Outcomes (1)

Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.
Induction

Study Arms (1)

treatment arm

EXPERIMENTAL

thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance

Biological: filgrastimBiological: sargramostimDrug: cyclophosphamideDrug: dexamethasoneDrug: melphalanDrug: prednisoneDrug: thalidomideProcedure: peripheral blood stem cell transplantation

Interventions

filgrastimBIOLOGICAL

PBSC collection: 10 mcg/kg SQ days 1-10

Also known as: G-CSF

treatment arm

sargramostimBIOLOGICAL

PBSC collection: 500 mcg/m2 SQ day 1 through last apheresis 1st and 2nd trans: 500 mcg SC or IV days 6-WBC recovery

Also known as: GM-CSF

treatment arm

cyclophosphamideDRUG

PBSC collection: 1 mg/m2 IV over 45-60 mins day 0

Also known as: cytoxan

treatment arm

dexamethasoneDRUG

40 mg/d PO days 1-4, 9-12, 17-20

Also known as: decadron

treatment arm

melphalanDRUG

1. st trans: 140 mg/m2 IV over 20 mins day -1 2. nd trans: 200mg/m2 IV over 20 mins day -1

treatment arm

prednisoneDRUG

maint: 50 mg/d PO every other day until progression

Also known as: steroid

treatment arm

thalidomideDRUG

ind: 50 mg increased by 50 mg every week to max 400 mg PO qhs for 35 days maint: 50 mg/d increased by 50 mg every week to 200 mg PO daily until progression

Also known as: thalomid

treatment arm

peripheral blood stem cell transplantationPROCEDURE

2-4 x 10\^6/kg IV day 0

Also known as: stem cell transplant

treatment arm

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Newly diagnosed multiple myeloma requiring treatment * Smoldering myeloma with evidence of progressive disease requiring chemotherapy * More than 25% increase in M component levels and/or Bence-Jones excretion or symptom development * Non-secretory patients with at least 30% bone marrow plasmacytosis * No IgM peaks unless there is evidence of more than 30% bone marrow plasmacytosis or more than 3 lytic lesions PATIENT CHARACTERISTICS: Age * 18 to 65 Performance status * Zubrod 0-2 OR * Zubrod 3-4 based solely on bone pain Life expectancy * Not specified Hematopoietic * No untreated, unresolved symptomatic hyperviscosity Hepatic * Hepatitis B negative Renal * Creatinine no greater than 3 mg/dL if in renal failure and on dialysis (after hydration and/or correction of hypercalcemia) Cardiovascular * No history of chronic cerebrovascular accident * No myocardial infarction within the past 6 months * No unstable angina * No congestive heart failure that is difficult to control * No uncontrollable hypertension * No cardiac arrhythmia that is difficult to control Pulmonary * No history of chronic obstructive or chronic restrictive pulmonary disease * No untreated, unresolved pneumonia * Pulmonary function tests (PFTs) at least 50% of predicted * DLCO at least 50% of predicted * Arterial partial pressure of oxygen greater than 70 if unable to complete PFTs due to bone pain or fracture Other * HIV negative * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No untreated, unresolved pathologic fractures * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use at least 2 highly effective methods of contraception for 4 weeks before, during, and for at least 4 weeks after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No more than 8 weeks of prior thalidomide therapy Chemotherapy * No prior chemotherapy for this disease Endocrine therapy * Prior steroid therapy allowed provided treatment duration was no more than 2 weeks Radiotherapy * No prior radiotherapy to more than 50% of the pelvis Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (141)

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of California Davis Cancer Center

Davis, California, 95616, United States

Location

Sutter Roseville Medical Center

Roseville, California, 95661, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342, United States

Location

Northside Hospital Cancer Center

Atlanta, Georgia, 30342, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

Location

WellStar Cobb Hospital

Austell, Georgia, 30106, United States

Location

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, 30033, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30045, United States

Location

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Southern Regional Medical Center

Riverdale, Georgia, 30274, United States

Location

Cancer Research Center of Hawaii

Honolula, Hawaii, 96813, United States

Location

OnCare Hawaii, Incorporated - Lusitana

Honolulu, Hawaii, 96813, United States

Location

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital, Incorporated

Honolulu, Hawaii, 96813, United States

Location

OnCare Hawaii, Incorporated - Kuakini

Honolulu, Hawaii, 96817, United States

Location

St. Francis Medical Center

Honolulu, Hawaii, 96817, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Kapiolani Medical Center at Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

St. Luke's Mountain States Tumor Institute - Boise

Boise, Idaho, 83712, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

St. Francis Hospital and Health Centers

Beech Grove, Indiana, 46107, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Stormont-Vail Cancer Center

Topeka, Kansas, 66604, United States

Location

St. Francis Comprehensive Cancer Center

Topeka, Kansas, 66606, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Louisiana State University Health Sciences Center - Monroe

Monroe, Louisiana, 71210, United States

Location

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, 71130, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, 49017, United States

Location

Bay Regional Medical Center

Bay City, Michigan, 48708, United States

Location

Mecosta County General Hospital

Big Rapids, Michigan, 49307, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Mercy Medical Center

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health Cancer Care - Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

Metropolitan Hospital

Grand Rapids, Michigan, 49506, United States

Location

Holland Community Hospital

Holland, Michigan, 49423, United States

Location

Hackley Hospital

Muskegon, Michigan, 49443, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Montana Cancer Consortium